Validity of Electronic Diary for Monitoring Varicose Veins Symptoms
Completed
- Conditions
- Varicose Veins
- Registration Number
- NCT01200199
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
The purpose of this study is to contribute to the validation of an electronic daily diary to assess symptoms in patients with varicose veins.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
- Sign informed consent and complete study assessments in written English
- Male or female age 18 to 75
- Patients having Saphenofemoral Junction (SFJ) incompetence and scheduled to receive foam sclerotherapy treatment for varicose veins in one leg
- Screening Symptom score of 7 points or more as measured by Question 1 on the modified VEINES-QOL/Sym questionnaire
Exclusion Criteria
- Unable to comply with completing a daily diary for a total of 24 days
- Participation in any other investigational pharmaceutical product, or device study within the 3 months prior to Visit 1
- Current venous leg ulcer in either leg
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the feasibility, variability, validity and sensitivity of patient's varicose vein symptoms using a disease-specific symptom questionnaire, administered as a daily electronic diary in patients undergoing treatment for varicose veins 8 weeks
- Secondary Outcome Measures
Name Time Method To establish the treatment effect size of foam sclerotherapy treatment 8 weeks